A Study on the Impact of a Nutraceutical Supplement on Oral Health and Microbiota in Children

A Multi-Center Open-label Interventional Pilot Clinical Study to Evaluate the Effectiveness of a Nutraceutical Formulation Containing Phosphatidylserine Probiotics Essential Oils and DHA in Improving Oral Microbiota and Overall Oral Health in Children. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089391

Enrollment

225

Registered

2025-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Hetafu Functional Candy: Participants(ages 5 14) will receive a fixed dosage of 2 candies per day for 6 weeks i.e 42 days Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects aged 5 14 years. No history of severe periodontal disease, recurrent oral infections, or advanced dental caries requiring medical intervention. No use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days prior to study enrollment. Willing to maintain regular oral hygiene practices during the study.

Exclusion criteria

Exclusion criteria: History of severe oral disease requiring medical intervention. Use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days before screening. Pregnant or lactating women. Known allergy to any ingredient in the Nutraceutical Formulation. Diagnosed gastrointestinal disorders that may interfere with probiotic absorption. Individuals currently enrolled in another clinical trial.

Design outcomes

Primary

Measure	Time frame
Reduction in Streptococcus mutans and Lactobacillus acidophilus levels from baseline to Week 6.Timepoint: At Week 6 Last microbiota sampling will be done i.e at 3rd follow up	—

Secondary

Measure	Time frame
To evaluate the reduction in halitosis over 6 weeks using a questionnaire. (based on the perception of the subject). Timepoint: At Week 6 a questionaire will be given to the patient i.e at 3rd follow up;To measure improvements in gingival health as assessed by Gingival Index scores.Timepoint: At Week 6 gingival scores will be taken again i.e at 3rd follow up;To analyze microbial balance shifts that reduce harmful bacterial strains like Streptococcus mutans and Lactobacillus acidophilusTimepoint: At Week 6 Last microbiota sampling will be done i.e at 3rd follow up	—

Measure

Time frame

To evaluate the reduction in halitosis over 6 weeks using a questionnaire. (based on the perception of the subject). Timepoint: At Week 6 a questionaire will be given to the patient i.e at 3rd follow up;To measure improvements in gingival health as assessed by Gingival Index scores.Timepoint: At Week 6 gingival scores will be taken again i.e at 3rd follow up;To analyze microbial balance shifts that reduce harmful bacterial strains like Streptococcus mutans and Lactobacillus acidophilusTimepoint: At Week 6 Last microbiota sampling will be done i.e at 3rd follow up

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Countries

India

Contacts

Public ContactDr Janhvi Bhole

Indian Dental Association

drlakshmi@idrf.org.in9742504911

Outcome results